Oral medicaments can assume a variety of dosage forms. Non-limiting examples of the most common solid dose forms include tablets, caplets, softgel capsules, solid-filled capsules, liquid-filled capsules, enteric-coated forms, sustained-release forms, solid lozenges, liquid-filled lozenges, mouth and throat drops, effervescent tablets, orally disintegrating tablets and combinations thereof. Oral compositions are typically swallowed immediately, or slowly dissolved in the mouth. These dosage forms may contain efficacious ingredients that have a disagreeable taste. Even for example upon compressing medicaments into a hardened tablet, the medicaments may provide the tablet with a disagreeable taste and, or odor. To overcome such bad flavors, solid dosage forms may be coated with materials including sugar or other sweeteners.
In the case of compressed tablets, the tablet cores are placed into coating pans where coating liquids are poured or sprayed over the tablet cores as they rotate in the pans. A repeated number of applications of the coating are made to achieve a determined coating thickness and pleasing aesthetic appearance. The coating's thickness is determined by a number of factors including masking any present objectionable taste, making the tablets easier to swallow and contributing to a specified dissolution rate of the tablets to effectuate dissolution in a target portion of the gastrointestinal tract for the optimum efficacy of the medicaments in the tablets.
Useful film coatings are generally thin and comprise crosslinked polymers. These coatings may comprise sweeteners and flavors, such as natural honey. Natural honey is an appealing flavor since consumers favor its taste and also perceive it as a safe and effective ingredient that positively impacts health and wellness.
Notwithstanding the implied positives, using natural honey in film coatings at levels sufficiently high that the tablets are realistically considered by consumers to contain natural honey, offers its own set of challenges when used in a film coating. Not the least of these challenges is that there is an inherent tackiness or stickiness of natural honey. Consumers have experienced this when dispensing liquid natural honey when used in one's home.
Even when a film coating containing natural honey dries, it is believed that the surface of the solid dosage form would remain noticeably sticky. This would not only creates a negative experience when consumers handle film coatings containing honey but it also would presents challenges when the solid doses are being packaged by the manufacturer. For example, typical tablet filling equipment comprises a bulk hopper where the solid dosage form such as tablets are fed from the hopper to packaging equipment for transferring the tablets into packaging such as bottles. Tablets must rapidly move to a filling portion of the packaging machine wherein the tablets are accumulated in a specified number and transferred into each bottle. Traditionally repeating rows of individual pockets for the solid dosage form are filled and eventually collected to be placed into the bottles. It is important, therefore, that the tablets freely flow from the hopper into the tablet collecting section of the machine and from there are dropped into the package. Even if sticky solid dosage forms were to be packaged on blistering equipment, possibly by hand, the tablets must slide freely over a sheet of polyethylene blister card into pockets of the card to fill each pocket before adhering to the blister card's foil or paper back sheet. If the solid dosage form adheres to the package or in the case of their being in bulk, to each other, there is a definite consumer negative since the solid dosage form is difficult to dispense and possibly may corrupts the designed solubility of solid dosage form in terms of its desired dissolution in the gastrointestinal tract making the tablet's ingredients less bioavailability than designed.
Therefore, there remains an unmet need to include significant levels of natural honey in film coatings on solid dosage forms that avoids anticipated problems associated with its inherent stickiness.